The Smileyscope System's Therapy Mode is a prescription-use intual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-1 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).

Device Description

Smileyscope is an immersive virtual reality (VR) device, consisting of Hardware and Software components. In Smileyscope Therapy mode, the device delivers 3-dimensional virtual reality treatment based on guided relaxation and other evidence-based behavioral methods to temporarily reduce pain and temporarily relieve acute procedural anxiety in individuals undergoing needle procedures. This prescription-use device uses pre-loaded software on a proprietary hardware and software platform to deliver treatment. The Smileyscope device is supplied with a USB charger and USB cable to facilitate charging.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Smileyscope System (Therapy Mode):

Background Note: This document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than presenting a full, detailed clinical study report. Therefore, some specific details about the study methodology (e.g., precise expert qualifications, detailed adjudication methods for ground truth) might not be explicitly stated in this type of summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Special Controls" applied to the predicate device, which the Smileyscope Therapy Mode aims to meet, and the "Clinical Performance Testing" results presented.

Acceptance Criteria (from Special Controls/Performance Goal)	Reported Device Performance (Smileyscope Therapy Mode)
I. Safety & Effectiveness Criteria related to Special Controls:
1. Clinical performance testing validates the model of behavioral therapy and evaluates all adverse events.	Met: Two independent randomized clinical studies published in The Journal of Pediatrics: - Emergency Department study (N=123): Nil adverse effects in treatment arm. - Outpatient Pathology study (N=129): 3 mild adverse effects in treatment arm. Overall, "safe, with no significant adverse effects." Adverse effects were mild (nausea, dizziness, headache, vomiting) and self-limiting.
2. Patient-contacting components are biocompatible.	Met: Biocompatibility evaluation performed per FDA guidance (ISO 10993-1:2018) for surface-contacting, limited duration (intact skin) components. Tests included Cytotoxicity, Sensitization, Intracutaneous Reactivity.
3. Software verification, validation, and hazard analysis performed.	Met: Documentation provided for "Minor" Level of Concern software, including requirements, traceability, revision history, V&V, hazard analysis, and cybersecurity.
4. Electromagnetic compatibility (EMC) and electrical, mechanical, and thermal safety testing performed.	Met: Conformance declared to harmonized standards (e.g., IEC 60950-1, EN 62368-1 for electrical safety; EN 301 489 series, EN 55032/55035 for EMC).
5. Labeling includes warnings for nausea/motion sickness, discomfort, and summary of clinical testing.	Implied Met: Labeling is listed as a migration measure for identified risks (nausea/motion sickness, discomfort, ineffective treatment, use error). A summary of clinical testing is provided in the 510(k) (and presumably in the actual labeling).
II. Clinical Effectiveness Criteria (from study results):
Temporarily reduce and/or manage pain (primary effectiveness endpoint).	Met: - Emergency Department study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.78 units with Smileyscope Therapy Mode vs. control (p=0.018). - Outpatient Pathology study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.39 units with Smileyscope Therapy Mode vs. control (p=0.034).
Temporarily relieve acute procedural anxiety (secondary effectiveness endpoint).	Met: Both studies "substantially reduced the secondary endpoint of procedural anxiety." (Specific quantitative results for anxiety are not provided in this summary table).

2. Sample Size Used for the Test Set and Data Provenance

The "test set" here refers to the subjects in the clinical performance studies.

Sample Size:
- Emergency Department study: 123 (64 in Smileyscope Therapy Mode arm, 59 in Control arm).
- Outpatient Pathology study: 129 (63 in Smileyscope Therapy Mode arm, 66 in Control arm).
- Combined N = 252 (Enrollment N=254, but treatment group totals 252).
Data Provenance:
- Country of Origin: "Outside of the United States only". The specific countries are not mentioned in this summary.
- Retrospective or Prospective: These were "randomized clinical studies" and referenced as "randomized controlled studies," implying a prospective design. Given that they are published in a peer-reviewed journal and were used for regulatory submission, this is a strong indication of prospective data collection.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The summary does not explicitly state the number of experts or their qualifications for establishing ground truth, as the primary effectiveness endpoint was "Child Self-Rated Pain (Faces Pain Scale-Revised)." This is considered a patient-reported outcome (PRO).
For the secondary endpoint of "procedural anxiety," again, no specific expert involvement for ground truth is mentioned. Procedural anxiety in children is often assessed using validated scales administered by trained researchers or clinicians, or through observational measures.

4. Adjudication Method for the Test Set

The summary does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the primary endpoint was child self-rated pain, and the studies were randomized controlled trials, the outcome measure itself (Faces Pain Scale-Revised) is directly reported by the patient. Adjudication of such an endpoint by external experts is generally not performed.
For other aspects of the study (e.g., adverse event reporting, study protocol adherence), there would have been standard clinical trial monitoring and oversight, but this is not detailed as a "ground truth" adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done in the context of human readers with vs. without AI assistance.
This device is a virtual reality behavioral therapy device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to deliver therapeutic content directly to the patient to reduce pain and anxiety, rather than to assist a human in interpreting data or making a diagnosis. The studies compared the device's therapeutic effect against a control condition.

6. Standalone Performance (Algorithm Only)

Yes, in essence, standalone performance was done for the "algorithm only" (the therapeutic virtual reality program). The studies measured the direct effect of the Smileyscope Therapy Mode on patients, where patients interacted solely with the device (software content running on specific hardware) and clinicians administered it.
There was no "human-in-the-loop" component in the sense of a human interpreting AI output or making decisions based on AI assistance. The human (clinician) used the device as a tool, and the "performance" here refers to the device's therapeutic effect on the patient, which was measured directly in the clinical trials against a control.

7. Type of Ground Truth Used

The primary ground truth used for effectiveness was patient-reported outcomes (PROs), specifically "Child Self-Rated Pain (Faces Pain Scale-Revised)."
For safety, reported adverse events were the ground truth.

8. Sample Size for the Training Set

The document does not mention a training set sample size. Because this device delivers virtual reality behavioral therapy, the "algorithm" is the behavioral therapy program itself, not a machine learning model that requires a separate training set in the typical sense.
The development of the VR experience and its behavioral techniques would have been informed by existing evidence-based behavioral methods, but this is a different concept than a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As there's no explicit mention of a machine learning training set in the document, establishing ground truth for such a set is not applicable here.
The "ground truth" for the device's therapeutic approach is implicitly based on "guided relaxation and other evidence-based behavioral methods" which are established practices in psychology and pain management. The clinical studies then validated if the VR delivery of these methods achieved the intended therapeutic effect.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2023

Smileyscope Holding Inc. Dr. Paul Leong Chief Medical Officer 701 Tillery Street #12 Austin, Texas 78702

Re: K230825

Trade/Device Name: Smileyscope System (Therapy Mode) Regulation Number: 21 CFR 890.5800 Regulation Name: Virtual reality behavioral therapy device for pain relief Regulatory Class: Class II Product Code: QRA Dated: August 28, 2023 Received: August 29, 2023

Dear Dr. Paul Leong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Amber T. Ballard -S

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230825

Device Name Smileyscope System (Therapy Mode)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	Smileyscope System (Therapy Mode)
Device Model:	SSVR US
Common Name:	Virtual Reality Behavioral Therapy Device
510(k) Number:	K230825
Manufacturer:	Smileyscope Pty Ltd1/333 Exhibition StMelbourne VIC 3000Australia
Sponsor:	Smileyscope Holding Inc701 Tillery Street #12Austin, TX 78702
Contact:	Paul LeongChief Medical Officer+1 888 300 7117
Prepared by:	MCRA, LLC803 7th St NWWashington, DC 20001Office: 202.552.5800
Date Prepared:	September 21, 2023
Classification:	21 CFR 890.5800 (Virtual Reality Behavioral Therapy Device FoPain Relief)
Class:	II
Product Codes:	QRA
Predicate Device:	EaseVRx (AppliedVR Inc), DEN210014

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Device Description:

Hardware:

The physical device consists of two major subcomponents (Figure 1 and Figure 2).

First, a detachable mobile interface, or "Faceplate", that clinicians can interact with via a touchscreen. The Faceplate contains an embedded mobile phone (Google Pixel 3) running Smileyscope software. Second, a head-mounted virtual reality headset, or "Main Body". The Main Body is placed on the patient's head and positioned via the Adjustable Head Strap. The Faceplate attaches to the Main Body via magnets (Figure 2, final step in Table 1). Lenses in the Main Body permit the display of virtual reality.

Image /page/4/Figure/5 description: The image shows a medical device with three labeled parts: faceplate, main body, and adjustable head strap. The faceplate has a screen that displays the word "Therapy" and options for age and session length. The main body is white and curved, and the adjustable head strap is teal and appears to be made of a flexible material. The device is designed to be worn on the head.

Figure 1: Smileyscope System, components labelled.

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Image /page/5/Picture/8 description: The image shows a SmileyScope device, which is a medical device used to assess pain in children. The device is white with a teal trim and has a head strap attached to it. The device has a screen that displays a smiley face, and there are two buttons on the top of the device, one green and one red. The device also has the word "smileyscope" printed on the side.

Figure 2: Smileyscope System, Front View, with Frontplate Attached to Main Body.

Software:

Clinicians use the Smileyscope System to administer the Smileyscope Therapy mode. In this software mode, the Smileyscope System provides evidence-based virtual reality behavioral therapy during a needle procedure.

While the patient undergoes the needle procedure in the real world, the Smileyscope Therapy Mode provides an interactive "underwater adventure" virtual reality experience. The virtual reality experience contains evidence-based guided relaxation and behavioral techniques designed to temporarily reduce pain and temporarily relieve acute procedural anxiety during needle procedures.

The underwater adventure can be configured by the Clinician to last 1-10 minutes. Audio cues are provided throughout the virtual reality experience which allow the clinician to synchronize the procedure with common needle-based procedures. However, precise timing is not necessary. The experience loops if the procedure takes longer than anticipated. The workflow is elaborated in Table 1.

The software has been designed to avoid common adverse effects associated with virtual reality. For example it contains minimal motion (to reduce motion sickness) and objects are positioned at optimal distances in the virtual environment so as to avoid virtual reality disequilibrium.

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Image /page/6/Figure/0 description: This image is a table describing the Smileyscope Therapy Mode Workflow. The table has two columns, one showing the Clinician Interface and the other providing a description. The Clinician Interface column shows three different screens: the Home Screen, the Smileyscope Therapy Menu, and the Body Part Selection screen. The Description column provides a description of each screen and how the clinician interacts with it.

Table 1: Smileyscope Therapy Mode Workflow

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Image /page/7/Picture/0 description: This image shows the Smileyscope Therapy system and its virtual reality capabilities. The top left shows the calibration screen, and the middle left shows how the faceplate attaches to the main body. The right side of the image describes how the Smileyscope Therapy system engages virtual reality and displays two images, one for each eye, during the calibration screen. The bottom left shows the underwater adventure virtual reality view, and the right side describes the virtual reality experience and how it mimics real-world needle experiences.

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Indications For Use:

The Smileyscope System's Therapy Mode is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-11 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).

Comparison of Technological Characteristics With The Predicate Device and Substantial Equivalence:

SubstantialEquivalenceCriteria	Primary Predicate	Subject Device	Comparison
Indication for Use	EaseVRx, AppliedVR IncEaseVRx is aprescription-useimmersive virtualreality system intendedto provide adjunctivetreatment based oncognitive behavioraltherapy skills and otherevidence-basedbehavioral methods forpatients (age 18 andolder) with a diagnosisof chronic lower back-pain (defined asmoderate to severepain lasting longer thanthree months). Thedevice is intended forin-home use for the	Smileyscope System(Therapy Mode)SmileyscopeHolding IncThe SmileyscopeSystem's TherapyModeis a prescription-useimmersive virtualreality systemintended to provideadjunctive treatmentbased on guidedrelaxation and otherevidence-basedbehavioral methodsfor patients aged 4-11years. TheSmileyscope TherapyMode isintended to temporarilyreduceand/or manage painand temporarilyrelieve acuteprocedural anxietyassociated withneedle procedures	Smileyscope is usedin a pediatricpopulation, whileEaseVRx is used inan adult population

Table 2: Summary of Substantial Equivalence Criteria, Primary Predicate, and Smileyscope System (Therapy Mode)

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	reduction of pain andpain interferenceassociated with chroniclower back pain.	(e.g., venipuncture, IVplacement,vaccination, portaccess, subcutaneousinjections). The deviceis not intended to treatanxiety disorders orspecific phobias (e.g.trypanophobia).
Intended Use	The device is intendedfor in-home use for thereduction of pain andpain interferenceassociated with chroniclower back pain.	The Therapy Modeis intended totemporarily reduceand/or manage painand temporarilyrelieve acuteprocedural anxietyassociated withneedle procedures	Both are intended toreduce pain
Clinical orscientific data thatdemonstrates thatthe device safe andeffective, and doesnot raise differentquestions of safetyand effectivenesscompared to thepredicate device.	Clinical and scientificdata: randomizedcontrolled studydemonstrating safetyand efficacy. (n=188)Randomized, multi-arm, "blinded" studywith concurrent shamcontrol. Location ofStudy not publiclyavailable in DecisionSummary.	Clinical andscientific data: tworandomizedcontrolled studiesdemonstrating safetyand efficacy.(combined n=254)Randomized, multi-arm, "blinded" studywith concurrent("active") control.Outside of UnitedStates only.	Both have RCTs witha large patientpopulation showingeffectiveness andsafety.

Table 3. Comparison of Technical Characteristics

SubstantialEquivalence Criteria	Primary Predicate	Subject Device	Comparison
	EaseVRx, AppliedVRInc	Smileyscope TherapySmileyscope HoldingInc
Headset Manufacturerand Model #	GoerTek Technology Inc.Model: A 7510/Pico G24K	Smileyscope HardwareModel: SSVR US	-
Rating	5V DC, 2A	5V DC/3A or 9V/2A	Similar

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Weight	278 (w/o Band), 470	530 grams	Similar, low risk characteristic
	(total)

Framerate in virtualreality (frame persecond)	72 fps	60 fps	Similar
Screen Resolution	3840 X 2160	2160x1080 pixels	Similar, low riskcharacteristic
Number of pixelshorizontally andvertically per eye	Horizontally: 1907Vertically: 1964	Horizontally: 1072Vertically: 1072	Similar, low riskcharacteristic
Luminance	Maximum: 0.06 nitsMinimum: 63.4 nits	2.4 to 426 nits	Similar1
Interpupillary distance(IPD) and IPD range ofthe headset	Default 63mm, opticaladaptive range is from55~71 mm	64mm, approximately 55-70mm usable range	Same
Tracking degrees ofheadset x/y/z 360°	3 degrees of freedom	3 degrees of freedom	Same
Eye relief forprescription lenses	17mm	16mm	Same
Field of view per eye	Horizontally: 98Vertically: 101	Horizontal: 90 degreesVertical: 90 degrees	Similar
Range in depths of thevirtual content in thesoftware	2m for optics; 3m forlauncher software	0.5m to infinitydepending on object(arms at ~0.5m, horizonat infinity)	Similar, notclinically relevant

Table 4. Comparison of Device Risks

Primary Predicate: Identified Risk toHealth	Smileyscope Therapy: Mitigation Measure
Adverse tissue reaction	Biocompatibility evaluationLabeling
Electric shock or burn or interference withother devices	Electromagnetic compatibility (EMC) testingElectrical, mechanical, and thermal safety testing
Nausea and motion sickness	Clinical performance testingLabeling
Discomfort	Clinical performance testingLabeling

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Ineffective treatment	Clinical performance testing
	Software verification, validation, and hazardanalysis
	Labeling
Use error or improper device use leading to	Labeling
a delay in treatment

1 Nathan Matsuda et al., "Realistic Luminance in VR," in SIGGRAPH Asia 2022 Conference Papers (SA '22: SIGGRAPH Asia 2022, Daegu Republic of Korea: ACM, 2022), 1-8, https://doi.org/10.1145/3550469.3555427.

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Special Controls were applied to the Primary Predicate. Smileyscope submits that these Special Controls have been met by Smileyscope Therapy Mode.

Table 5: Special Controls applied from the Primary Predicate

Special Control from Primary Predicate

(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Software verification, validation, and hazard analysis must be performed.

(4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.

(5) Labeling must include the following:

(i) A warning regarding the risk of nausea and motion sickness

(ii) A warning regarding the risk of discomfort from the device

(iii) A summary of the clinical testing with the device

Performance Testing Summary:

The Smileyscope has undergone performance testing in line with FDA guidance documents, commensurate with the Predicate Device.

Hardware

Smileyscope's hardware has undergone performance testing. A summary is presented below.

Headset	Smileyscope Hardware
Rating	5V DC/3A or 9V/2A
Weight	530 grams
Framerate in virtual reality	60 frames per second (fps)
Screen Resolution	2160x1080 pixels
Horizontal and Vertical pixels per eye	1072 x 1072 (horizontal x vertical) pixels per eye
Luminance	2.4 to 426 nits
Interpupillary distance and range	64mm, approximately 55-70mm usable range
Tracking degrees of headset x/y/z 360 degrees	3 degrees of freedom
Eye relief for prescription lenses	16mm
Field of view per eye	90 degrees90 degrees

Table 6: Technical specifications

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Biocompatibility

The physical device is constructed of materials found in the Primary Predicate and FDA cleared products (e.g. PC/ABS, silicone etc.). The patient contacting components have undergone Biocompatibility Evaluation per FDA guidance "Use of International Standard ISO 10993-1:2018, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). The patient contacting components are categorized as surface contacting with limited contact duration (less than 24 hours) of intact skin. Assessment of the device included the following tests according to the contact classification and duration of the patient-contacting materials:

Cytotoxicity (ISO 10993-5:2009) ●
Sensitization Test (ISO 10993-10:2010) ●
Intracutaneous Reactivity (ISO 10993-10:2010) ●

Electrical Safety and Electromagnetic Capability

The embedded mobile phone hardware has undergone electromagnetic compatibility and electrical, mechanical, and thermal safety testing and declared conformance to the following harmonized standards and normative documents:

Electrical Safety:

IEC 60950-1:2005 + A1:2009 + A2:2013
EN 60950-1:2006 + A11:2009 + A1:2010 + A12:2011 + A2:2013 ●
IEC 62368-1:2014, EN 62368-1:2014 + A11:2017
EN 62311:2008, EN 62479:2010 ●
EN 50360:2017, EN 62209-1:2016 ●
EN 50566:2017, EN 62209-2:2010 .

Electromagnetic Compatibility:

Draft EN 301 489-1 v2.2.0 ●
Final Draft EN 301 489-3 V2.1.1 ●
Draft EN 301 489-17 V3.2.0
Draft EN 301 489-19 V2.1.0 ●
Draft EN 301 489-52 V1.1.0 .
EN 55032:2015/AC:2016 Class B ●
. EN 55035:2017

Software

The sponsor provided documentation for software with a "Minor" Level of Concern (LoC), as described in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." issued May 11, 2005. Documentation describing the software, software requirements specification, traceability, revision level history, verification, validation, hazard analysis and cybersecurity provides the foundation that the software will operate in a manner as described in the specifications.

Clinical Performance Testing

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Smileyscope Therapy Mode has undergone Clinical Performance Testing. Smileyscope Therapy Mode was tested in two independent randomized clinical studies, which have been peer-reviewed and published in the Journal of Pediatrics2. Briefly, in both studies Smileyscope Therapy Mode, consistently demonstrated benefits for the primary endpoint of child-rated pain, and substantially reduced the secondary endpoint of procedural anxiety. The pre-specified primary safety and effectiveness endpoints were met in both studies, which were conducted outside of the United States only, in comparable population(s). These are summarized in Table 3 below. Overall, Smileyscope Therapy Mode was safe, with no significant adverse effects, specifically with regards to the Identified Risks to Health from the Primary Predicate's Special Controls. Adverse effects were mild (nausea, dizziness, headache, vomiting) and were self-limiting; they did not require pharmacotherapy.

Stage	SmileyscopeTherapy Mode Total	Control Arm Total	Total
Emergency Department study
Enrollment	64	59	123
Treatment	64	59	123
Primary Safety Endpoint	Nil adverse effects	4 mild adverse effects
Primary Effectiveness Endpoint: Change in Child Self-Rated Pain (Faces Pain Scale-Revised)	-1.39	+0.39
Between-Group Difference	-1.78 units pain reduction with SmileyscopeTherapy Mode(95% CI, -3.24 to -0.32)p=0.018
Outpatient Pathology study
Enrollment	63	68	131
Treatment	63	66	129
Primary Safety Endpoint	3 mild adverse effects	3 mild adverse effects
Primary Effectiveness Endpoint: Change in Child Self-Rated Pain (Faces Pain Scale-Revised)	+1.37	+2.76
Between-Group Difference	-1.39 units pain reduction with SmileyscopeTherapy Mode(95% CI, -2.68 to -0.11)p=0.034

Table 7: Summary of Smileyscope Therapy Mode Clinical Performance Testing
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2 Evelyn Chan et al., "Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials," The Journal of Pediatrics 209 (April 29, 2019): 160–67, https://doi.org/10.1016/j.jpeds.2019.02.03

Conclusion:

Smileyscope Therapy Mode and the predicate device have intended use, have different technological characteristics, with appropriate clinical and scientific data that demonstrates the device is as safe and effective as a legally marketed device, and there are no different questions of safety and effectiveness than the predicate. The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as the Primary Predicate Device.

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Regulation Number and Section

§ 890.5800 Virtual reality behavioral therapy device for pain relief.

(a)
Identification. A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(5) Labeling must include the following:
(i) A warning regarding the risk of nausea and motion sickness;
(ii) A warning regarding the risk of discomfort from the device; and
(iii) A summary of the clinical testing with the device.